Pharmaceutical Research & Consulting

Helping clients navigate FDA and Health Canada regulations since 2002

Years in Service
Projects Completed

The dicentra advantage

Our interdisciplinary pharmaceutical team has combined experience in drug applications and submissions, quality management, regulatory compliance, and clinical trials

Our Pharmaceutical Services


Drug Applications & Submissions

  • New Drug Applications (NDA) including 505(b)(1) & 505(b)(2) applications
  • Abbreviated new drug applications (ANDA) and supplemental new drug applications (SNDA)
  • Investigational New Drug (IND) applications
  • Drug Establishment Registration and Labellor code request
  • Over-the-counter (OTC) Drug Product Registration
  • New Drug Submission (NDS)
  • Abbreviated New Drug Submission (ANDS) and Supplement to a New Drug Submission (SNDS)
  • Drug Identification Number (DIN) application
  • Drug Establishment Licence (DEL)
  • Non-Prescription (OTC) drug registration
  • Non-prescription drug monograph attestation
  • Prescription to OTC Switch (Rx to OTC)

Quality Systems Compliance Services

  • Good Manufacturing Practice (GMP) Services
  • Good Laboratory Practice (GLP) Services
  • Good Clinical Practice (GCP) Services
  • Strategy and risk analysis
  • QMS design and development
  • QMS audit and assessment against FDA 21 CFR Part 201
  • QMS audit and assessment against Part C, Division 2 of Canada’s Food and Drug Regulations
  • QMS verification and improvement
  • SOP & PnP preparation and review
  • Third-party CGMP Audit
  • Quality system training

Regulatory Compliance

  • Drug classification (monograph vs. new drug; prescription vs. non-prescription)
  • Determine whether your product meets Generally Recognized as Safe and Effective (GRASE) conditions
  • Changes Being Effected (CBE) filing, Changes Being Effected in 30 days (CBE 30) filing
  • Annual Report preparation
  • Prior Approval Supplement (PAS)
  • Notifiable Change (NC) & Notice of Compliance (NOC)
  • Major change, moderate change, minor change reporting
  • Annual Drug Notification Form (ADNF) preparation
  • Drug Labelling
  • Adverse event reporting/Adverse reaction reporting

Clinical Trials

  • Pre-clinical trials
  • Pharmacokinetics/Pharmacodynamics (Pk/Pd)
  • Bioequivalence studies
  • Recruitment
  • Phase I/IIa Clinical Trials
  • Phase II/III Clinical Trials
  • Phase IV/Post marketing surveillance
  • Pharmacovigilance
  • Biostatistics

Let's Work Together